Syringe needles are typically covered with protective sheaths prior to use, and it is desirable to resheath needles after use, including resheathing during multiple syringe use applications, and for needle disposal purposes. Consequently, the unsheathing, resheathing and disconnecting of sheathed needles from syringe bodies are procedures which are repeatedly carried out by doctors, nurses, technicians and the like.
As readily appreciated by such individuals, the above-noted procedures can become tedious and raise cross-contamination concerns, particularly when manual grasping of a sheath is required. Additionally, such procedures can result in "needle sticks", i.e., the inadvertent pricking of a hand. For example, needle sticks can occur when, during manual resheathing, a syringe needle misses the relatively small opening of a sheath and pricks the hand in which the sheath is being grasped. While a needle stick does not initially give rise to serious injury, the threat of communicating serious diseases, such as hepatitis and AIDS, is of great concern.
Various approaches have been proposed to address the above-noted problems. For example, syringes have been developed which include a telescoping shield member that can be selectively pulled over a syringe needle after use. Another new syringe includes a needle that can be retracted into the syringe body after use. These products are prohibitively expensive for most applications, and have proven to be subject to leakage and other contamination problems.
Of particular importance, a number of independent apparatus for assisting in syringe needle unsheathing, resheathing and disposal have been proposed. For example, U.S. Pat. No. 4,485,918 to Mayer, discloses a funnel-shaped apparatus, adapted to be hand-held by the tubular portion thereof. The tubular portion has a closed-end and is of a limited length so that, if the apparatus is held upright, a sheath can be supported within the apparatus and reapplied to a syringe needle. In addition to the inconvenience associated with the required upward orientation for sheath support and resheathing, it should be noted that the above-described Mayer apparatus does not include any features for selective removal of a sheath from a syringe needle.
Mayer further discloses a separate apparatus for assisting in resheathing and in the disconnection of a sheathed needle from a syringe body and the disposal thereof. Specifically, Mayer shows a box-shaped apparatus having an aperture in the ceiling with radially extending slots. In use, Mayer proposes that a sheath can be manually inserted into the aperture and supported about its flange by the adjacent ceiling portion. A needle can then be inserted into the sheath until resheathing is achieved. Mayer further proposes that a sheathed needle assembly can be pressed through the aperture due to ceiling flex permitted by the slots, moved laterally to cause abutting engagement between the needle hub and the adjacent ceiling portion, and that the syringe body can thereafter be pulled, and if necessary, twisted upward to cause disconnection of the needle assembly from the syringe body. It should be noted that this apparatus is not adapted to be handheld and fails to disclose any features for selective removal of a sheath from a needle. In addition, the apeture/slot arrangement of the apparatus would seem to accommodate only certain sizes of sheaths for successful resheathing and disposal, and would appear to be particularly subject to wear. Further, the apparatus requires either mechanical anchoring or manual holding during needle disconnection procedures.
U.S. Pat. No. 4,596,562 to Vernon, and U.S. Pat. No. 4,717,386 to Simmons, both disclose apparatus for assisting in the unsheathing, resheathing and/or handling of syringe needles wherein means for retaining engagement of a sheath are employed. In particular, the Vernon and Simmons apparatus each require forcible entry of a sheath into a restricted opening to effectuate sheath engagement and retention by the periphery of the opening.
For example, Vernon discloses a generally planar apparatus having at least one hole therethrough of a diameter corresponding to a diameter found along the length of typical tapered sheaths. Vernon also contemplates the provision of a slot at the top end of the disclosed apparatus, defined by two parallel, spaced plates, with a pie-shaped opening extending downward from one of the plates to accommodate access to the slot. Vernon proposes that, at least for resheathing, a sheath can be forced into either the opening or the slot until restrictive engagement between the outer periphery of the sheath and the periphery of the opening or slot occurs. A syringe needle can then be inserted into the supported sheath until resheathing is achieved, and subsequently removed from the apparatus by manual grasping and pulling of the sheath to cause disengagement. It is important to appreciate that such a procedure necessitates the initial inward positioning of a sheath to a specific location within an opening to effectuate retention, and the application of opposing forces to achieve both sheath engagement and disengagement. Such requirements present particular operational problems when the apparatus is to be handheld. Further, significant cross-contamination can occur between a sheath and a user's hand or glove during manual disengagement of a sheath from the Vernon apparatus. Finally, the contemplated handle of the Vernon apparatus is spatially removed from the proposed sheath retaining means, thereby contributing to needle/sheath alignment difficulties associated with resheathing.
In the disclosed Simmons apparatus, a cylindrical member with converging inner walls extends laterally away from a plate-like member. Simmons proposes that by forcing a sheath into the opening of the cylindrical member of the apparatus, restrictive engagement between the inner walls of the member and the periphery of the sheath can be achieved. Upon consideration, it is apparent that, as with the Vernon apparatus, initial sheath engagement necessitates specific sheath positioning and the provision of opposing forces. In addition, disengagement of a sheathed needle from the Simmons apparatus would entail the inconvenient grasping of a sheath by a user and could result in undesired cross-contamination. Further, it would seem that the sheath retaining means of the Simmons apparatus is particularly subject to significant wear as the result of the repetitive rubbing of sheaths against the innerwalls of the cylindrical member.
French Pat. No. 2,586,568 to Putscher discloses a safety holder for the sheath of a hypodermic syringe needle. A cylindrical body has a leaf spring and a spring trigger of a limited length projecting outward from the cylindrical body. Due to the length and outward projection of the spring trigger from the cylindrical body, the Putscher device does not accommodate a transferse gripping and application of pressure thereto by the majority of a user's hand. Thus, the Putscher device does not provide a convenient holder capable of easy use by various persons of varying hand and finger strength.
In view of the disadvantages corresponding with the above-noted, representative apparatus, it is apparent that a substantial need exists for a safe and convenient apparatus for assisting in initial needle unsheathing, sheath retention, syringe holding, needle resheathing, and sheathed needle disconnection and disposal procedures. Such an apparatus is singularly provided by the novel features incorporated into the present invention.